Kornimate/medical-research-clean huggingface dataset:
evaluation of lidocaine spray versus dexmetomidine spray on stress response

Conditions: To Measure Systolic Blood Pressure Postintubation

Summary: many studies discussed attenuating stress response by various measures but to the interest of our study , no one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs ,

this study will be conducted in the operating theatres of cairo university hospitals. patients undergoing any surgery under general anesthesia and needs endotracheal intubation using direct laryngoscopy will be assigned to one of the three groups: group c: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation group l: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation group d: : will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation.

Eligibility criteria:
inclusion criteria: * • asa i,ii * age 18-60y * patients scheduled for any operations under general anesthesia and needs endotracheal intubation using direct laryngoscopy in the operating theatre. exclusion criteria: * • uncontrolled high blood pressure \> 160/100 heart disease in the form of ischemic heart disease and severe valvular disease. * patients with the history of allergy to lidocaine or dexmedetomidine. * asa iii \& iv. * patients refuse to share in this study * suspected difficult intubation that needs more than 2 trials.
myotonometer intra- and inter examiner reliability on spinal muscular atrophy

Conditions: Muscle Tone Poor; Spinal Muscular Atrophy

Summary: the primary aim of the study was to measure the intra-rater and inter-rater reliability of myotonpro in measuring postural muscle tone and mechanical properties in individuals with spinal muscular atrophy (sma). the secondary aim is to question the existence of a relationship between the functional levels of individuals with sma and their muscle tone and biomechanical properties. it is assumed that the outputs to be obtained from this research will form the norm data for moyotonometer evaluation in children with sma.

it seems to be important to examine peripheral changes in the pathogenesis of sma. although it shows that the target center in sma is alpha motor neurons located in the anterior horn of the spinal cord, considering the interaction network of interneurons, cerebellum, neuromuscular junction, gamma-alpha motor neuron pool, descending and ascending pathways, and reflex arc, it has potential to be investigated in individuals with sma. this suggests that it may have important consequences for peripheral mechanisms. it may be important to examine muscle mechanical properties to reveal any potential correlations between sma types and disease progression. in addition, moyotonometer results can be a key evaluation method in examining treatment efficacy, diagnosis and disease course. however, in order for these activities to be observed with myotonometer, first of all, the reliability of its use in individuals with sma should be questioned.

Eligibility criteria:
inclusion criteria: * between 0-4 years old * diagnosed with spinal muscular atrophy (sma) * children who continue their medical treatment at home and are not in intensive care * children of families who agreed to participate in the study and approved the informed consent form. exclusion criteria: * children of families who disagreed to participate in the study
a pharmacokinetic (pk) study of pf-00299804 and dextromethorphan in healthy volunteers

Conditions: Healthy Volunteers

Summary: a study to study the potential effect of pf-00299804 inhibition of cyp2d6 on dextromethorphan.


Eligibility criteria:
inclusion criteria: * healthy male and/or female of non childbearing potential subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * subjects must be cyp2d6 extensive metabolizers, ultrarapid metabolizers or intermediate metabolizers, as predicted by cyp2d6 genotyping. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen. * history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink =5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening. * treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication. * 12 lead ecg demonstrating qtc \>450 msec at screening. if qtc exceeds 450 msec, the ecg should be repeated two more times and the average of the three qtc values should be used to determine the subject's eligibility. * use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. depo provera® must be discontinued at least 6 months prior to the first dose of study medication. as an exception, acetaminophen/paracetamol may be used at doses of \<1 g/day. limited use of non prescription medications that are not believed to affect subject safety or the overall results the study may be permitted on a case by case basis. * blood donation of approximately 1 pint (500 ml) within 56 days prior to dosing. * history of sensitivity to heparin or heparin induced thrombocytopenia. * unwilling or unable to comply with the lifestyle guidelines described in this protocol.

Keywords: drug-drug interaction study cyp2d6 inhibition healthy subjects
anti-insulin-like growth factor-1 receptor (igf-1r) antibodies in graves' disease and graves' orbitopathy

Conditions: Graves Ophthalmopathy; Graves Disease; Autoimmune Thyroiditis

Summary: the study is aimed at assessing igf-1r-abs in patients with graves' disease, with or without go, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation.


Eligibility criteria:
inclusion criteria: 1. for graves' disease: a history of hyperthyroidism, associated with previous or present detectable serum autoantibodies against the tsh-r; 2. for autoimmune thyroiditis: the presence of at least two of the following: a) primary hypothyroidism; b) detectable serum autoantibodies against thyroglobulin or thyroperoxidase ; c) a hypoechoic pattern of the thyroid by ultrasound examination. 3. for healthy subjects: absence of any clinical, biochemical or instrumental evidence of thyroid diseases. for all subjects: informed consent exclusion criteria: 1) lack of informed consent
of patient education related to cv risk factors in type 2 diabetes mellitus(patrol).

Conditions: Low Density Lipoprotein Cholesterol Goal Achievement

Summary: an observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity crp (hs-crp) testing and characteristics of each cvd risk group.


Eligibility criteria:
inclusion criteria: * subjects who was diagnosed as diabetes * subjects who was diagnosed as dyslipidaemia or takes lipid lowering medication * clinic visit in the past 6 months more than once exclusion criteria: * subjects who are unwilling or unable to provide their examination and lab result of medical chart.

Keywords: ada recommendation
investigation to evaluate the safety and effectiveness of cochlear implantation in children and adults with unilateral hearing loss/single-sided deafness

Conditions: Hearing Loss, Unilateral; Deafness, Unilateral

Summary: the aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with unilateral hearing loss (uhl)/single sided deafness (ssd) supporting a change indication for use.


Eligibility criteria:
inclusion criteria: • individuals 18 years or older (group a) ear to be implanted: severe sensorineural hearing loss (hl) defined as: pure-tone average at 0.5, 1, 2, 4 khz \>80 db hl ; aided consonant-nucleus-consonant test (cnc) score ≤5% and normal hearing ear: normal or near normal hearing defined as an average of (0.5, 1, 2, 4khz) ≤ 30 db hl • children 5 years to 17 years, 11 months (group b) ear to be implanted: severe sensorineural hl defined as: pure-tone average at 0.5, 1, 2, 4 khz \>80 db hl; aided cnc score ≤5% and normal hearing ear: normal or near normal hearing defined as an average of (0.5, 1, 2, 4khz) ≤ 30 db hl * previous experience with a current conventional treatment option for unilateral \[ssd\] hl (ha, bone-conduction device, or cros technology), if no previous experience a minimum trial period of two weeks is required * english spoken as a primary language * willing and able to provide written informed consent exclusion criteria: * ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array * previous cochlear implantation * hearing loss of neural or central origin, including auditory neuropathy * duration of profound sensorineural hl \>10 years per self-report * active / chronic middle-ear infection; conductive hl in either ear * medical or psychological conditions that contraindicate undergoing surgery as determined by the investigator * unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the investigator * evidence of and/or suspected cognitive or developmental concern * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator * investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling * cochlear employees or employees of contract research organizations (cros) or contractors engaged by cochlear for the purposes of this investigation * pregnant or breastfeeding women * currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
turp; complications and outpatient care

Conditions: Benign Prostatic Hyperplasia

Summary: this study aims to investigate the impact of transurethral prostate resection in regard to complications. these are direct surgical complications, such as bleeding, infection and readmissions, as well as the long term complications as incontinence and impotence. also, the study aims to investigate if selected cases of patients could be performed as outpatient surgery, thereby reducing cost.

transuretral prostate resection (tur p) is a common procedure to relieve voiding problems in men. after the introduction of bipolar resection with saline, the serious complication of transurethral resection syndrome (i.e. acute hypo-natremia) has been eradicated. the post surgical care is generally a couple of days inhospital care. the reson for this, is the risk of clot formation and in rare cases post surgical infection. however, in selected cases, outpatient surgery has been performed with encouraging results. however, the technique has not been spread widely. the use of ambulatory surgery would reduce the direct cost of the procedure, thereby increasing it´s availability. also, complications in contemporary tur p in the modern era (outside of the selected patients of clinical trials) is lacking. the information of complications that can be expected is therefore an important for patient counseling. in some studies, the use of incontinence pads after tur p is more than 15%, which is important to reliably ascertain if this is holds true.

Eligibility criteria:
inclusion criteria: * planned for transurethral resection of the prostate (tur p) exclusion criteria: * no consent to participate

Keywords: prostate resection incontinence erectile dysfunction
biological standardization of poa pratensis allergen extract

Conditions: Allergy to Grass Pollen

Summary: the objective of this study is to determine the biologic activity of a poa pratensis allergen extract in histamine equivalent prick (hep) units, in order to be used as in-house reference preparation (ihrp).

this is an open, unblinded and non-randomized biological assay. the study design is a slight modification of the recommendations proposed by the nordic guidelines. four concentrations of poa pratensis allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility criteria:
inclusion criteria: 1. a documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to poa pratensis. 2. subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable). 3. subject can be male or female of any race and ethnic group. 4. age \> 18 years and \< 50 years at the study inclusion day. 5. positive skin prick test with a standardized commercially available preparation of poa pratensis allergen extract. the skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study 6. a positive test for specific ige to poa pratensis(cap-rast ≥ 2). ige results are valid if performed within one year prior to the inclusion of the subject in the study. 7. allergic symptoms during the pollen season of poa pratensis. 8. mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm. exclusion criteria: 1. immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts). 2. use of drugs that may interfere with the skin reactions (e.g., antihistamines). see appendix 1 3. treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent). 4. pregnancy. 5. dermographism affecting the skin area at the test site at either study visit. 6. atopic dermatitis affecting the skin area at the test site at either study visit. 7. urticaria affecting the skin area at the test site at either study visit. 8. participation in another clinical trial within the last month. 9. subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,...)

Keywords: immunotherapy skin prick test standardization poa pratensis
safety and immunogenicity study of revaccination with scb-1019t in healthy adults

Conditions: RSV Infection

Summary: clo-scb-1019-002 is the first study of scb-1019t vaccine for revaccination in older adults who were previously vaccinated with arexvy. the safety, tolerability and immunogenicity of scb-1019t are assessed.

the study design will compare heterologous revaccination with scb-1019t, homologous revaccination with arexvy, or placebo in adults who were previously vaccinated with arexvy. the sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. the study will be overseen by a safety monitoring committee.

Eligibility criteria:
inclusion criteria: 1. male and female participants 60-85 years of age at the screening visit and who received arexvy before. 2. individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. 3. individuals willing and able to give an informed consent, prior to screening. 4. healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment). please refer to protocol for full list of inclusion and exclusion criteria. exclusion criteria: 1. acute disease or fever (≥38°c) at time of vaccination. participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. for participants with minor illness and/or fever at the time of vaccination, visit 1 may be rescheduled within the allowed time-window. 2. recurrent or un-controlled neurological disorders or seizures. 3. serious or unstable chronic illnesses 4. any history of dementia or any medical condition that moderately or severely impairs cognition 5. history of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines. please refer to protocol for full list of inclusion and exclusion criteria.
acthar gel for chronic pulmonary sarcoidosis (acps)

Conditions: Sarcoidosis; Pulmonary Sarcoidosis

Summary: an randomized trial of two maintenance doses of acthar gel for patients with chronic pulmonary sarcoidosis. patients will be observed for 24 weeks of treatment.

this is a multi-center double-blind trial to determine dose and effect size. a total of 20 chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the united states. after initial evaluation, including pulmonary function, ct and pet scanning, patients will be randomized to receive 80 units if acthar gel daily for 10days, followed by either 40 or 80 units of acthar gel twice a week for an additional 22 weeks. at the end of total 24 weeks of treatment, they will undergo repeat evaluation including pulmonary function, ct, and pet scanning.

Eligibility criteria:
inclusion criteria: * patient with biopsy confirmed sarcoidosis meeting american thoracic society criteria 23 * patient on \>5 mg prednisone for pulmonary indications * fvc \<85% predicted * prednisone dose not reduced in prior 3 months * deterioration of pulmonary disease over the past year * decrease in fvc \>5% * age: 18 through 90 (i.e., candidates must have had their 18th birthday, but not had their 91st birthday). exclusion criteria: adrenal insufficiency (addison's disease) * scleroderma * a fungal infection * herpes infection of the eyes * osteoporosis * a stomach ulcer * congestive heart failure * high blood pressure * recent surgery * if you are allergic to pork proteins * do not receive a smallpox vaccine or any "live" vaccine while you are using corticotropin. * patients receiving anti-tumor necrosis factor antibody (e.g. infliximab, adalimumab) in prior six months * uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of glucocorticoids * patients requiring therapy for pulmonary hypertension * females of childbearing potential who are known to be pregnant and/or lactating or who have a positive urine pregnancy test on screening. * current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days) * any other condition that the investigator feels would pose a significant hazard to the patient if acthar gel therapy is initiated.

Keywords: prednisone, methotrexate, sarcoidosis, azathioprine
safety of btds in subjects with low back pain: a 52-week extension phase of bup3015

Conditions: Back Pain Lower Back Chronic

Summary: the purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (btds). subjects begin the extension phase on btds 5 mcg/h and may up- or down-titrate the dose \[up to btds 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.

buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility criteria:
inclusion criteria: * subjects who completed all visits of the double-blind phase on study drug, and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase. * for subjects entering the extension, 4 electrocardiograms (ecgs) are required at entry if none were collected prior to randomization while on btds 20. note: subjects with any 1 qt data corrected for heart rate using the fridericia formula (qtcf) interval ≥ 500 milliseconds (msec) would be discontinued from the extension phase exclusion criteria: * subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study.

Keywords: low back pain opioid transdermal
the effect of orthokeratography on the quality of life and behavior of myopic children

Conditions: Myopia

Summary: the study intended to observe the changes in the quality of life, behavior, and eye habits of children and adolescents aged 8-18 years before and after orthokeratology, as well as the differences in the quality of life and behaviors of different myopic groups after keratoplasty, using the eq-5d-y, chu9d, and chrome-g scales with the use of a self-assessment method.


Eligibility criteria:
inclusion criteria: * spherical equivalent ranged -1.00d from-5.00d * optimal corrected visual acuity ≥1.0 in both eyes * no apparent strabismus or other eye disease * able to read chinese and communicate in mandarin, able to understand the questions in the questionnaire exclusion criteria: * a history of corneal surgery within 1 year * eyelid abnormalities or infection * an inability to wear orthokeratology * use medications that affect the wear of eye and corneal contact lenses * those who have participated in a clinical trial of a drug within 90 days * allergic patients who have used contact lenses and/or care products * the researchers consider it inappropriate to participate in this program